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Device Classification & Regulatory Pathways
Medical devices are divided into Classes I through IV by risk, and the Korean pathway varies by class and category.
Class I commonly begins with a notification pathway, Class II with certification or approval review, and Classes III and IV with approval review. Product-specific characteristics and technical-document review requirements still need confirmation against current rules.
Classes and typical pathways
| Class | Application pathway |
|---|---|
| I | Notification |
| II | Certification or approval |
| III | Approval |
| IV | Approval |
Product information for classification
| Area | Points to confirm |
|---|---|
| Intended use | Explain what the product diagnoses, treats or supports. |
| Operation and configuration | Describe its principle, components/materials, software and associated products. |
| Evidence | Prepare the product description and any existing authorization information for comparison. |
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
Clarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.